On Jan. 30, President Trump issued what is now known as the “2-for-1” (or 2:1) executive order, directing federal agencies that promulgate any new regulation to offset the cost by rescinding two existing regulations. As a follow up, on Feb. 24, he issued the Task Force executive order, directing each agency to establish a task force charged with a range of deregulatory responsibilities.

Under the 2:1 order, the cost of any significant new regulation (or guidance) must be offset by rescinding two of equal cost.

Under the subsequent order, each agency must establish a Regulatory Reform Task Force. In addition, within 60 days, each agency must appoint a Regulatory Reform Officer (RRO) to oversee regulatory reform initiatives and policies to ensure that agencies effectively carry out reforms. The RRO will chair the task force within each agency. At this point, OMB has issued some guidance on the 2:1 order; guidance will be forthcoming on the Task Force order.

Although the FDA has an internal staff of expert economists who will be tasked with estimating costs of regulations under these orders, we anticipate that it will still be a significant undertaking for the agency to rescore targeted existing regulations and to score new initiatives.

It’s important to keep in mind that there are nuances in both orders, and a lot will be determined by how OMB and agency leadership, such as a confirmed FDA commissioner, interpret some of these requirements. We explore each of these orders and the OMB guidance in further detail in our recent article in Pharmaceutical Online.

But the bottom line is that we see these deregulatory executive orders as an opportunity; strategic companies, trade associations and patient groups may seek ways to craft credible cost estimates to share with the FDA and the Trump Administration to advance their policy priorities, whether they are withdrawals or advancement of significant regulations.

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